Evidence map›Paper›PMID 34857843›Full record

Trial reportScientific reports2021

A multicenter, randomized, active-controlled, clinical trial study to evaluate the efficacy and safety of navigation guided balloon Eustachian tuboplasty.

Sung-Won Choi, Se-Joon Oh, Yehree Kim, Min Young Kwak, Myung-Whan Suh, Moo Kyun Park, Chi Kyou Lee, Hong Ju Park, Soo-Keun Kong

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Balloon Dilation for Chronic Eustachian Tube Dysfunction Under Local and General Anesthesia: A Systematic Review and Meta-Analysis.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale
    Pooled it
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  5. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Sung-Won ChoiDepartment of Otorhinolaryngology-Head and Neck Surgery, Pusan National University School of Medicine, Biomedical Research Institute, Pusan National University Hospital, Gudeok-ro 179, Seo-Gu, Busan, 49241, Republic of Korea.
Se-Joon OhDepartment of Otorhinolaryngology-Head and Neck Surgery, Pusan National University School of Medicine, Biomedical Research Institute, Pusan National University Hospital, Gudeok-ro 179, Seo-Gu, Busan, 49241, Republic of Korea.
Yehree KimDepartment of Otorhinolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Min Young KwakDepartment of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, Eulji University, Daejeon, Republic of Korea.
Myung-Whan SuhDepartment of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, Seoul, Republic of Korea.
Moo Kyun ParkDepartment of Otorhinolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Chi Kyou LeeDepartment of Otorhinolaryngology-Head and Neck Surgery, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, Republic of Korea.
Hong Ju ParkDepartment of Otorhinolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Soo-Keun KongDepartment of Otorhinolaryngology-Head and Neck Surgery, Pusan National University School of Medicine, Biomedical Research Institute, Pusan National University Hospital, Gudeok-ro 179, Seo-Gu, Busan, 49241, Republic of Korea. entkong@gmail.com.
Pusan National University Hospital · KRSeoul National University Hospital · KRAsan Medical Center · KREulji University · KRSoonchunhyang University · KRUlsan College · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To assess the safety and efficacy of navigation-guided balloon Eustachian tuboplasty (BET) compared to medical management (MM) alone in patients with chronic Eustachian tube dilatory dysfunction (ETD). This is a prospective, multicenter, 1:1 parallel-group, randomized controlled trial (RCT). It aims to assess the efficacy of navigation-guided BET compared to MM alone in patients with chronic ETD. The primary outcome measure was an improvement in the Eustachian tube dysfunction questionnaire (ETDQ)-7 score at the 6-week follow-up compared with baseline. Secondary outcome measures included changes in the signs and symptoms during the follow-up, changes in the score for each subcategory of ETDQ-7, type of tympanometry, pure tone audiometry, and the availability of a positive modified Valsalva maneuver. Navigation-guided BET was safely performed in all patients. A total of 38 ears of 31 patients (19 ears of 16 patients in the BET group and 19 ears of 15 patients in the control group) completed the planned treatment and 6 weeks of follow-up. More patients in the BET group (1.99 ± 0.85) had less symptomatic dysfunction than in the control group (3.40 ± 1.29) at 6 weeks post-procedure (P = 0.001). More patients experienced tympanogram improvement in the BET group at 6 weeks compared to the control group (36.5% vs. 15.8%) with a positive modified Valsalva maneuver (36.6% vs. 15.8%, P = 0.014). Additionally, air-bone gap change was significantly decreased in the BET group compared to the control group at the 6-week follow-up visit (P = 0.037). This prospective, multicenter, RCT study suggests that navigation-guided BET is a safe and superior treatment option compared to MM alone in patients with chronic ETD.

Indexed as

AdultChronic DiseaseDilatationEar DiseasesEustachian TubeFemaleFollow-Up StudiesHumansMaleMiddle AgedOtologic Surgical ProceduresProspective StudiesSafetySurgery, Computer-AssistedTreatment Outcome

Identifiers

PMID34857843
PMCPMC8639820
OpenAlexW3216017042

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.